QFK

Tumor Gene Profiling Test

Product code: QFK
Device name: Tumor Gene Profiling Test
Device class: Class N
Medical specialty: Unknown
Marketing pathway: Contact ODE

FDA classification definition

A next-generation sequencing based tumor profiling test is a qualitative in vitro diagnostic test intended to detect mutations in a broad panel of targeted genes that are somatically altered in malignant neoplasms from nucleic acids isolated from human clinical specimens obtained from patients diagnosed with malignant neoplasms using targeted next-generation sequencing.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QFK

Classification and pathway per current FDA publications. Data from openFDA (CC0).